MAUDE Adverse Event Report: ST. JUDE MEDICAL BRASIL LTDA. EPIC STENTED PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number EL-23A

Device Problems Gradient Increase (1270); Material Too Rigid or Stiff (1544); Torn Material (3024)

Patient Problems Aortic Insufficiency (1715); Infarction, Cerebral (1771)

Event Type  Injury  

Event Description

On (b)(6) 2006, a 23 mm sjm epic supra valve was implanted.In (b)(6) 2017, during the patient's annual transthoracic echo, mild to moderate ar was observed.In (b)(6) 2017, the patient presented with a cerebral infarction.On (b)(6) 2017, a tee was completed which revealed the source of the embolus was from the laa that had recanalized after surgical closure in 2006.Also during the tee, severe central aortic regurgitation was noted with preserved ef and no dilatation of the lv.The mean gradient of the aortic valve was also slightly elevated at 29 mmhg in (b)(6) 2017 compared to 21 mmhg postoperatively in (b)(6) 2006.On (b)(6) 2018, the 23 mm sjm epic supra valve was explanted and a tear was found on the free edge of the leaflet and stiffening was reported.The valve was replaced with a 25 mm trifecta gt valve (sn (b)(4)).The patient is reported to be stable.

Manufacturer Narrative

Product evaluation: an event of aortic regurgitation was reported.The results of the investigation concluded that cusps 2 and 3 were torn at the free edge.There was circumferential fibrous pannus ingrowth on the inflow surface of all three cusps.An outflow surface thrombus was noted on cusp 3.No acute inflammation was present in the valve.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2006, a 23mm sjm epic valve was implanted and laa closure was performed.In (b)(6) 2017, during the patient's annual transthoracic echo, mild to moderate ar was observed.In (b)(6) 2017, the patient presented with a cerebral infarction.On (b)(6) 2017, a tee was completed which revealed the source of the embolus was from the laa that had recanalized after surgical closure in 2006.The tee also demonstrated severe central aortic regurgitation with preserved ef and no dilatation of the lv.The mean gradient of the aortic valve was also slightly elevated at 29mmhg (immediately post-op mean gradient was 21mm).On (b)(6) 2018, the 23mm sjm epic valve was explanted and a tear was found on the free edge of the leaflet and stiffening was reported.The valve was replaced with a 25mm trifecta gt valve (sn (b)(4)).The patient is reported to be stable.

• Brand Name: EPIC STENTED PORCINE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA.; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA.; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7227923
• MDR Text Key: 98574183
• Report Number: 3001743903-2018-00003
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2007
• Device Model Number: EL-23A
• Device Catalogue Number: EL-23A
• Device Lot Number: 2971353
• Other Device ID Number: 05414734007290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR